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kholden

Recruiting participants for study on Vit. D and Parkinson's

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Effects of Vitamin D in Parkinson's Disease (PD)

 

 

This study is currently recruiting participants.

Verified April 2013 by Department of Veterans Affairs

Sponsor:

Department of Veterans Affairs

Collaborator:

Oregon Health and Science University

Information provided by (Responsible Party):

Department of Veterans Affairs

 

ClinicalTrials.gov Identifier:

NCT01119131

First received: April 23, 2010

Last updated: April 9, 2013

Last verified: April 2013

History of Changes

triangle.gif Purpose

 

A trial to measure the effects of vitamin D (versus a placebo) on balance, gait, falls, strength, and cognition in persons with Parkinson's disease.

 

Condition Intervention Phase Parkinson Disease

Accidental Falls Drug: Vitamin D

Dietary Supplement: calcium

Other: Placebo Phase 2

Study Type: Interventional Study Design: Allocation: Randomized

Endpoint Classification: Safety/Efficacy Study

Intervention Model: Parallel Assignment

Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary Purpose: Treatment Official Title: The Effects of Vitamin D on Balance in Persons With PD

 

Resource links provided by NLM:

 

 

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Calcium Falls Parkinson's Disease Vitamin D

Drug Information available for: Calcium Gluconate Vitamin DU.S. FDA Resources

 

Further study details as provided by Department of Veterans Affairs:

 

 

Primary Outcome Measures:

  • Change in static and dynamic balance as recorded using dynamic posturography with the sensory organization test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

 

Secondary Outcome Measures:

  • Change in ambulatory balance as recorded using iMOBILTY with an instrumented timed up and go to measure turn duration [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in strength as recorded by measuring knee flexion and extension using Biodex [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in cognition as recorded using a battery of tests to look at executive function, visuospatial function, and attention [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Fall rates over the 16 weeks of the study as recorded using patient diaries [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in quality of life as recorded using multiple quality of life scales [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 140 Study Start Date: May 2011 Estimated Study Completion Date: June 2015 Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions Active Comparator: Arm 1

Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium Drug: Vitamin D

Vitamin D at 10,000 IU a day Dietary Supplement: calcium

1000mg calcium daily Placebo Comparator: Arm 2

Will be on placebo and 1000mg of calcium. Dietary Supplement: calcium

1000mg calcium daily Other: Placebo

A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm

[/url] Detailed Description:

 

The proposed study is a randomized, double-blinded, placebo controlled intervention trial to measure the effects of vitamin D at (10,000IU/day) versus placebo on balance and falls in Parkinson's disease. We will measure static, dynamic, and ambulatory balance, as well as strength, falls, and cognition before and after 16 weeks of therapy. Dynamic posturography will be used to measure static and ambulatory balance, a device called iMOBILITY will measure a timed up and go, and strength will be measured with the Biodex machine checking knee flexion and extension. Multiple quality of life and cognitive tests will also be performed.

triangle.gif Eligibility

 

 

Ages Eligible for Study: 50 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Criteria

 

Inclusion Criteria:

  • Parkinson's disease;
  • ability to ambulate 50 feet;
  • ability to cooperate with balance testing;
  • vitamin D level less than 40ng/ml;
  • balance problems;
  • ability to walk 50 feet without the help of another person

Exclusion Criteria:

  • MMSE < 25;
  • another neurological or orthopedic deficit that in the examiner's opinion would affect testing;
  • history of renal stones or hypercalcemia;
  • unwillingness to not be on other vitamin D supplementation during the study

triangle.gif Contacts and Locations

 

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119131

 

 

Contacts Contact: Brenna M Lobb (503) 220-8262 ext 51871 Brenna.Lobb@va.gov

Locations United States, Oregon VA Medical Center, Portland Recruiting Portland, Oregon, United States, 97201 Contact: Brenna M Lobb 503-220-8262 ext 51871 Brenna.Lobb@va.gov Principal Investigator: Amie Peterson, MD BS

Sponsors and Collaborators

Department of Veterans Affairs

Oregon Health and Science University

Investigators Principal Investigator: Amie Peterson, MD BS VA Medical Center, Portland

triangle.gif More Information

 

No publications provided

 

Responsible Party: Department of Veterans Affairs ClinicalTrials.gov Identifier: NCT01119131 History of Changes Other Study ID Numbers: B7051-W Study First Received: April 23, 2010 Last Updated: April 9, 2013 Health Authority: United States: Federal Government

United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:

Vitamin D

Parkinson disease

accidental falls

Additional relevant MeSH terms:

Parkinson Disease

Parkinsonian Disorders

Basal Ganglia Diseases

Brain Diseases

Central Nervous System Diseases

Nervous System Diseases

Movement Disorders

Neurodegenerative Diseases

Calcium, Dietary Vitamin D

Ergocalciferols

Vitamins

Bone Density Conservation Agents

Physiological Effects of Drugs

Pharmacologic Actions

Micronutrients

Growth Substances

ClinicalTrials.gov processed this record on April 16, 2013

 

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10,000 iu's of Vitamin D certainly sounds like a boatload. Somehow that doesn't sound beneficial. HA... from the Mayo website:

"the recommended dietary allowance (RDA) for most adults of 600 IU of vitamin D a day.".

 

I think I will skip this trial.

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Yes, it is a very high level. However, a number of conditions, such as breast cancer, asthma, type I diabetes, autoimmune diseases, and PD, are associated with deficiency; and in some cases, unusually high amounts of vitamin D -- even higher than 10,000 IUs -- have ameliorated symptoms. The researchers want to find out if this could be true for PD. I am keeping my fingers crossed that this will be the case, because it would be a noninvasive, inexpensive means of reducing symptoms.

 

The question (well, in my mind) is -- does PD result from a deficiency of vit. D, or is deficiency caused by PD? If the latter, then repletion might not be the solution.

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